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Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (PRIMULTI)

This study is ongoing, but not recruiting participants.
Aalborg Universitetshospital
Information provided by (Responsible Party):
Thomas Engstrom, Rigshospitalet, Denmark Identifier:
First received: October 9, 2013
Last updated: October 17, 2016
Last verified: October 2016
In patients with ST-elevation myocardial infarction (STEMI) the primary treatment is acute angioplasty of the acute occlusion (culprit lesion). In STEMI patients with multi vessel disease (MVD) no evidence based treatment of the non-culprit lesions exists. We aim to provide evidence as to whether full revascularization or revascularization of the culprit lesion only provides the best prognosis for the patient.

Condition Intervention
ST-elevation Myocardial Infarction.
Multi Vessel Disease.
Procedure: Percutaneous coronary intervention
Procedure: FFR

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Primary PCI in Patients With ST-elevation Myocardial Infarction and Multivessel Disease: Treatment of Culprit Lesion Only or Complete Revascularization (DANAMI-3-PRIMULTI) A Randomised Comparison of the Clinical Outcome After Complete Revascularisation Versus Treatment of the Infarct-related Artery Only During Primary Percutaneous Coronary Intervention

Resource links provided by NLM:

Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • All cause death, myocardial infarction or revascularization [ Time Frame: 1 year ]
    Composite of all cause mortality, myocardial infarction, or ischemia (either subjective or objective) driven revascularization of non-culprit coronary lesions eligible for and randomized to either of the two treatment arms at the time of the index procedure

Secondary Outcome Measures:
  • Cardiac death or myocardial infarction [ Time Frame: 1 year ]
  • Hospitalization for acute coronary syndrome or acute heart failure [ Time Frame: 1 year ]
  • Angina status and quality of life [ Time Frame: 1 year ]
  • Infarct size in relation to area at risk as determined by MRI [ Time Frame: 3 months ]
  • Cardiac death, myocardial infarction, repeat revascularisation or occurrence of definite stent thrombosis (according to ARC definition) of non culprit lesions [ Time Frame: 2 years ]
  • Wall motion index (WMI) determined by echocardiography [ Time Frame: 1 year ]

Estimated Enrollment: 650
Study Start Date: May 2011
Estimated Study Completion Date: February 2019
Primary Completion Date: February 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Culprit lesion revascularization
Only the culprit lesion is treated whereas other study lesions are left un-treated.
Procedure: Percutaneous coronary intervention
Active Comparator: Full revascularization
Culprit lesion is treated initially and all other lesions with diameter stenosis angiographically >50% and FFR <0.80 are treated in a separate procedure within the index hospitalization. Stenoses > 90% are treated without prior FFR.
Procedure: Percutaneous coronary intervention Procedure: FFR

Detailed Description:

STEMI patients with MVD (30% of total STEMI population) are - following successful primary angioplasty - randomized to either no additional percutaneous coronary intervention (PCI) of other lesions or full revascularisation guided by fractional flow reserve (FFR).

Eligible coronary arteries must be >2.0 mm in diameter and at the discretion of the operator suitable for PCI. Only arteries with angiographically stenoses > 50% can be randomized. All randomized lesions with diameter stenosis > 50% and < 90% are evaluated by FFR and a FFR value < 0.80 is considered significant and treated. Stenoses >90% are treated without prior FFR.

Full revascularization is a priori obtained by means of PCI. If, however, PCI is considered inferior to coronary artery bypass grafting the latter option can be chosen.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Age ≥ 18 years.
  • Acute onset of chest pain of < 12 hours' duration.
  • ST-segment elevation ≥ 0.1 millivolt in ≥ 2 contiguous leads, signs of a true posterior infarction or documented newly developed left bundle branch block.
  • Culprit lesion in a major native vessel.
  • MVD (non-culprit vessels with angiographic stenosis >50%)
  • Successful primary PCI

Exclusion Criteria:

  • Pregnancy.
  • Known intolerance of acetylsalicylic acid, clopidogrel, heparin or contrast.
  • Inability to understand information or to provide informed consent.
  • Haemorrhagic diathesis or known coagulopathy.
  • Stent thrombosis
  • Significant left main stem stenosis
  • Cardiogenic shock at admittance
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Please refer to this study by its identifier: NCT01960933

Aalborg University Hospital
Aalborg, Denmark, 9100
Rigshospitalet, University of Copenhagen
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Aalborg Universitetshospital
Study Chair: Steffen Helqvist, MD, DMSci Rigshospitalet, University of Copenhagen, Denmark
Principal Investigator: Thomas Engstrøm, MD, DMSci Rigshospitalet, University of Copenhagen, Denmark
Principal Investigator: Henning Kelbæk, MD. DMSci Rigshospitalet, University of Copenhagen, Denmark
Principal Investigator: Lars Køber, MD, Prof., DMSci Rigshospitalet, University of Copenhagen, Denmark
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Thomas Engstrom, MD, Senior Consultant, DMSCi, Rigshospitalet, Denmark Identifier: NCT01960933     History of Changes
Other Study ID Numbers: DANAMI-3-PRIMULTI
Study First Received: October 9, 2013
Last Updated: October 17, 2016

Keywords provided by Rigshospitalet, Denmark:
Full revascularization
Culprit lesion revascularization only
Primary PCI

Additional relevant MeSH terms:
Myocardial Infarction
Pathologic Processes
Myocardial Ischemia
Heart Diseases
Cardiovascular Diseases
Vascular Diseases processed this record on May 24, 2017